The principles of Quality by Design were introduced in ICH Q8(R1) in November 2008. Since then, it became clear that there was a need for further clarity and several sets of Q&As were published up to November 2010. Subsequently, a joint EMA/FDA pilot program was set up, with the PMDA as an observer, in March 2011, to ensure consistent interpretation of the Quality by Design concepts and to attempt to harmonise as much as possible regulatory assessments and decisions across the US and the EU.
In 2014, the decision was made to extend the program and finally it concluded in April 2016 with 14 assessment procedures completed under the program, consisting of 2 MAA/NDAs, 3 variations and 9 requests for scientific advice.
Throughout the pilot program, additional Q&As were prepared and published jointly by the EMA and the FDA, and the resulting conclusion at the end of 5 years was that there is firm alignment between the two agencies in how the concepts of ICH Q8(R1), Q9 (Quality Risk Management) and Q10 (Quality Management System) should be implemented and interpreted. This conclusion was also supported by two precedent-setting applications that were reviewed during the pilot program, namely a continuous manufacturing based application and a post-approval change management protocol. The consultative advice pathway assessment of these two applications resulted in harmonisation of the regulatory expectations of both agencies in terms of the levels of detail, considerations for risk-based approaches, real-time release testing, and strategies and models for validation and control.
The EMA and the FDA are considering further joint programs including expedited/accelerated assessments such as PRIME and Breakthrough Therapy status (which you can read more about in our white paper “Early access schemes, part 1 of 2“.
The FDA/EMA report can be found here.